Associate Scientific Director Cover Letter

I submit this application to express my sincere interest in the associate scientific director position.

In the previous role, I was responsible for business, scientific expertise, recommendations on projects associated with ELSIP assets in Preclinical Drug Development, Clinical Drug Development, Chemistry, Medicinal Chemistry, Pharmacovigilance and Pharmacoepidemiology, Precision Medicine, and Pharmaceutical Modelling and Simulation.

Please consider my experience and qualifications for this position:

• Able to think creatively in the science/regulatory/nutrition space while remaining within regulatory boundaries
• Strong communication, influencing and external presence skills
• Previous experience as a professor, preceptor or other scientific teaching role preferred
• Uses past experiences and learning to determine how to deal successfully with the future
• Demonstrated comprehensive skills in establishing and maintaining collegial peer-to-peer relationships with a wide range of external thought leaders including physicians, pharmacists, and allied healthcare professionals
• Adapts communication style to the audience in order to be heard
• Demonstrates sensitivity and understanding toward others at all levels and functions within the organization
• Remains empathic and supportive under pressure

I am excited to be applying for the position of associate scientific director. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for stewardship, toxicology and/or pathology support and interpretation of toxicology studies on drug candidates with subsequent preparation and review of regulatory documents and support of Regulatory Affairs and Clinical groups for all phases of development, including IND through registration across all therapeutic indications.

Please consider my experience and qualifications for this position:

• Drug Product Development experience that a span early through late is preferred
• Maintains awareness of applicable legal, regulatory and compliance framework and good research/publication practices applicable to health economics and outcomes research
• The scope of role will initially be limited to 1-3 tumor types
• Publications experience/CMPP experience strongly preferred
• Scientific expertise in oncology preferred
• Experience working in highly matrix environment across a broad range of functional areas
• Collaborate with key internal stakeholders to ensure externally facing activities achieve their Medical/Scientific goals in preparation for launch activities in oncology
• Attend conferences, symposia and training courses

I would like to submit my application for the associate scientific director opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for leadership in the areas of therapeutic design, development and delivery to pre-clinical drug discovery programs across the ImmunoDermatology portfolio of innate, adaptive and tissue immunity.

My experience is an excellent fit for the list of requirements in this job:

• Expertise across all aspects of scientific publication strategy, planning and execution during all phases of drug development and commercialization process (investigational, registrational, pre & post-launch and marketed)
• Scientific expertise in cardiovascular preferred
• Experience working in highly matrix environment across an Alliance and with a broad range of functional areas and collaborating with the Medical Affairs, Health Outcomes, R&D
• Understanding of the clinical trial design and execution, statistical methods and clinical trial data reporting requirements
• Previous leadership experience (coaching, mentoring, leading projects) is preferredR&D
• Experience interacting with Regulatory Agencies including experience in authoring toxicology sections of regulatory documents
• Previous leadership experience (coaching, mentoring, leading projects and subteams) is preferred
• Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process

I am excited to be applying for the position of associate scientific director. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for input and support to the TA clinical development team for clinical research / development activities intended to support product registration, and for post approval commitments such as regulatory agency mandated trials.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• High level of competence in Microsoft Word (some experience with Excel is beneficial)
• High level of competence with document templates and electronic submissions
• Coordinate and manage medico-scientific advisory board meetings
• Manage development and production of all scientific communication material for Medical Information booths at congresses
• Coordinate gathering of scientific intelligence for a specific therapeutic area at key congresses
• And collation thereof into a usable data package
• Develop and coordinate key scientific messages for a specific therapeutic area
• Collaborate with key internal stakeholders to ensure externally facing activities achieve their Medical/Scientific goals in preparation for launch activities in a specific TA

I am excited to be applying for the position of associate scientific director. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for critical input on discovery and nonclinical development strategy including peer review of pharmacology/pharmacokinetic protocols, reports, and regulatory content.

Please consider my qualifications and experience:

• Able to deliver in uncertain, ambiguous, complex environments with high level of change
• Subject matter competence in publication and scientific content field including execution across all phases of drug development and commercialization, good publication practices and guidance (GPP3, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices, scientific data communication, and transparency & conflict-of-interest environments
• Preparation of an integrated biomarker development plan linked to a specific trial in close collaboration with discovery research, biomarker subject matter experts, global clinical development and other relevant functions
• Contributes to biomarker data analysis and interpretation with bioinformatics and biostatistics
• Participates and contributes to the next generation immuno-oncology CDx development such as indication agnostic strategy
• Authors/reviews biomarker related sections in regulatory submission and response documents
• Review of specific analytical biomarker method
• Review of clinical and laboratory documents for each specific trial (including but not limited to LSD, LES, CTP, CTP amendments)